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Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression

NCT ID: NCT00727584

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-08-31

Brief Summary

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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating metastatic spinal cord compression.

PURPOSE: This randomized clinical trial is comparing two radiation therapy regimens to see how well they work in treating patients with metastatic spinal cord compression.

Detailed Description

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OBJECTIVES:

* To examine whether a phase III randomized study comparing a single-fraction of radiotherapy with multi-fraction radiotherapy is acceptable to clinicians and to patients with metastatic spinal cord compression.
* To determine the feasibility of conducting this study in the United Kingdom.

OUTLINE: This is a multicenter study. Patients are stratified by treatment center and known prognostic factors (ambulatory status at diagnosis, primary tumor type, and extent of disease \[spinal metastases only vs spinal and non-bony metastases\]). Patients are randomized to 1 of 2 treatment arms.

* Arm I (multi-fraction radiotherapy): Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.
* Arm II (single-fraction radiotherapy): Patients undergo 1 fraction of 8 Gy external beam radiotherapy.

Patients undergo assessment of ambulatory status, quality of life, bladder and bowel function, and acute toxicity via self-reported questionnaires and telephone follow-ups at baseline and weeks 1, 4, 8, and 12.

Conditions

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Spinal Cord Compression Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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spinal cord compression unspecified adult solid tumor, protocol specific

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Study Groups

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Arm I (multi-fraction radiotherapy)

Patients undergo 5 fractions of 20 Gy external-beam radiotherapy.

Group Type ACTIVE_COMPARATOR

radiation therapy

Intervention Type RADIATION

Patients undergo external beam radiotherapy

Arm II (single-fraction radiotherapy)

Patients undergo 1 fraction of 8 Gy external beam radiotherapy.

Group Type EXPERIMENTAL

radiation therapy

Intervention Type RADIATION

Patients undergo external beam radiotherapy

Interventions

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radiation therapy

Patients undergo external beam radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed malignant disease
* Proven diagnosis of metastatic spinal cord compression on MRI or CT scan

* Single site of compression OR multiple sites that can be treated within a single radiation treatment field
* No patient for whom surgery or chemotherapy treatment is more appropriate
* No multiple myeloma as primary cancer

PATIENT CHARACTERISTICS:

* Life expectancy \> 1 month
* Not pregnant
* Willing and able to complete assessment forms
* Able to give informed consent

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research UK

OTHER

Sponsor Role lead

Principal Investigators

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Peter J. Hoskin, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Vernon Cancer Centre at Mount Vernon Hospital

Locations

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Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

Site Status

Cancer Research UK and University College London Cancer Trials Centre

Northwood, England, United Kingdom

Site Status

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, United Kingdom

Site Status

Christie Hospital

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CRUK-UCL-BRD-07-010

Identifier Type: -

Identifier Source: secondary_id

CRUK-SCORAD

Identifier Type: -

Identifier Source: secondary_id

ISRCTN97555949

Identifier Type: -

Identifier Source: secondary_id

EU-20863

Identifier Type: -

Identifier Source: secondary_id

CDR0000599886

Identifier Type: -

Identifier Source: org_study_id